Description
Pioneering Medicines, Flagship Pioneering's in-house drug development unit, is dedicated to conceiving and developing life-changing treatments for patients built from Flagship's innovative platforms.
The Clinical Development Lead (Medical Director or Senior Medical Director level) is a Physician-Scientist who plays a pivotal role on Pioneering Medicines (PM) project teams by driving the successful transition of programs from research into early clinical development.
Responsibilities:
- Lead the design of early clinical development plans (through human proof-of-concept) for PM programs, in alignment with the Target Product Profile (TPP).
- Collaborate closely with senior clinical leaders, Project Leaders, Research, Strategy, and external advisors/KOLs to define and refine clinical hypotheses and development strategies.
- Integrate clinical plans with translational, nonclinical, and regulatory development strategies to enable seamless progression from exploratory studies to first-in-human trials.
- Partner with Research teams,including Pharmacology, Translational Sciences, and Nonclinical Development,to align research outputs with clinical objectives.
- Work with the Strategy Group to ensure clinical plans support the TPP and the overall program value proposition.
- Incorporate regulatory input, operational feasibility, and real-world data to ensure robust and executable development strategies.
- Collaborate with Project Management to develop integrated timelines, resource forecasts, and budget assumptions for incorporation into NewCo planning.
- Support the preparation and delivery of key materials for internal governance forums and Joint Steering Committees (JSCs) with external partners.
- Identify and address development risks and bottlenecks proactively; drive resolution across functional interfaces.
- Promote a culture of scientific rigor, accountability, agility, and open collaboration within project teams.
- Enhance cross-functional integration by facilitating communication, alignment, and shared ownership of development goals.
Qualifications:
- Physician Scientist: MD or MD with PhD with a robust scientific background.
- 3+ years or more of post-graduate/post-residency experience in industry or academic clinical research.
- Medical residency completion required.
- Subspecialty fellowship training is highly preferred.
- Strong understanding of early clinical development and translational medicine, mechanisms of disease, and patient care paradigms in relevant therapeutic areas (oncology, immunology, and/or metabolic diseases preferred).
- Demonstrated excellence in scientific rigor, operational decision making, risk mitigation, and innovation.
- Proven leadership and effective communication skills, with the ability to collaborate and convey strategic implications to diverse stakeholders.
- Excellent oral, written, and presentation skills for engaging stakeholders and fostering teamwork.
- Strong strategic thinking and critical thinking skills for identifying and addressing bottlenecks while optimizing cross-functional processes.
- Proactive and adaptable in demanding environments, with an operational mindset to improve efficiency and achieve strategic goals.
Benefits:
- Healthcare coverage.
- Annual incentive program.
- Retirement benefits.
- Broad range of other benefits.